Artificial Intelligence
Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer
– New IND Expands Liver Disease Pipeline for CRV431 –
– IND Clearance Allows CRV431 to Move Directly into Phase 2 for Hepatocellular Carcinoma Treatment –
– New IND Provides for Complementary Therapeutic Approach of Treating NASH and Liver Cancer with a Single Once-a-Day Oral Agent –
EDISON, N.J., Dec. 21, 2021 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its investigational new drug (“IND”) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (“HCC”).
On July 29, 2019, Hepion received FDA authorization of an IND to initiate the study of CRV431 for the treatment of NASH. To date, Hepion has completed Phase 1 studies in healthy volunteers and, more recently, announced positive data from its Phase 2a ‘AMBITION’ trial in subjects with presumed F2 and F3, where CRV431 was well tolerated, and all primary endpoints were met. A larger Phase 2b NASH study of over 300 subjects with paired liver biopsies, called ‘ASCEND-NASH’, is expected to be initiated in 2022. ASCEND-NASH will evaluate CRV431’s effects on the histologic endpoints of liver steatosis and fibrosis over 12 months dosing.
“Liver cancer is the sixth most prevalent cancer worldwide and is the second most common cause of cancer death,”1 commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “The most common form of liver cancer is HCC, which comprises about 90% of all liver cancers. Major risk factors associated with development of HCC include NASH, liver fibrosis and cirrhosis, viral hepatitis, chronic alcohol consumption, and metabolic syndrome. As the global prevalence of NASH is increasing, the incidence of HCC arising from NASH is also increasing. Approximately 25% to 30% of NASH-related HCC develops in the absence of cirrhosis and, therefore, occurs without many of the symptomatic warning signs of this aggressive form of cancer. An orally administered drug that simultaneously targets NASH and HCC would offer an advantageous therapeutic strategy to patients suffering these potentially life-threatening conditions. CRV431’s novel potential stems from its pleiotropic pharmacologic activities and from its ability to target the liver, allowing for a drug candidate ideally suited for the treatment of liver disease.”
Dr. Hobbs continued, “Another potentially important benefit is the patient experience while taking CRV431. Most cancer drugs are delivered by injection and are associated with significant side effects. In contrast, CRV431 is orally administered and has been shown to be well tolerated in clinical trials to date. We are optimistic that CRV431 may provide significant anti-cancer effects without imposing additional challenges and distress often associated with cancer drugs.”
Robert Foster, PharmD, PhD, Hepion’s CEO, said, “Increased cyclophilin isoform expression has been associated with negative outcomes in HCC. Importantly, CRV431 potently inhibits many of these isoforms in humans. Cyclophilins are enzymes that regulate many molecular and cellular activities that become dysregulated both in NASH and HCC. These dysregulated activities can lead to aberrations in signal transduction pathways, cell proliferation, cell death, extracellular environment including increased fibrosis, energy metabolism, inflammation, and immunity. Therapeutic intervention with CRV431 administration may reduce the pathologic potential associated with heightened cyclophilin activities in NASH and HCC, potentially allowing for a return to a healthier state.”
Dr. Foster continued, “CRV431 has shown anti-tumor activity in multiple animal studies, and our research team has been intensively investigating the specific mechanisms that have produced these outcomes. Our investigations have revealed interesting direct and indirect effects of CRV431 on cancer cells and tumors. For example, gene expression analyses have demonstrated CRV431’s ability to attenuate drug-resistance pathways and Wnt-β-catenin-Myc signaling, the latter being mutationally over-activated in 30% to 50% of human HCC tumors. We recently also found that CRV431 increased lymphocyte infiltration into liver tumors in a manner similar to an immune checkpoint inhibitor, also known as an anti-PD-1 antibody, which is considered to be an important anti-tumor approach. We believe that the wide array of pharmacologic activities offered by CRV431 in the treatment of NASH and HCC should bode well for the further clinical development in both important indications.”
Reference
1Hepatocellular Carcinoma. Nature Reviews Disease Primers 7, 7 (2021).
About Hepion Pharmaceuticals
The Company’s lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for CRV431 to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]
USA News Group Commentary
VANCOUVER, BC, April 25, 2024 /PRNewswire/ — Across several sectors the use of artificial intelligence (AI) is making a huge impact, with healthcare emerging as possibly receiving the largest boost. According to a new research report from analysts at Mordor Intelligence, the market for artificial intelligence in health care is set to explode at a CAGR of 42.20% through 2029. As the tech sector races to provide the market with solutions, several companies are emerging as leaders in aiding the healthcare sector, including Avant Technologies Inc. (OTC:AVAI), Microsoft Corporation (NASDAQ:MSFT) (NEO:MSFT), Health Catalyst, Inc. (NASDAQ:HCAT), Ginkgo Bioworks Holdings, Inc. (NYSE:DNA), and Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX).
Recently, Avant Technologies Inc. (OTC:AVAI) strengthened its AI-powered healthcare offerings by acquiring Wired-4-Health, a company specializing in healthcare technology and data services. This addition supports Avant’s goal to create the first supercomputing network in the country. This network will offer big data and AI software companies a quicker, more potent, and more affordable computing infrastructure.
“Our strategy behind this acquisition was to enable Avant to deliver best-in-class data and system interoperability support services to the healthcare and life sciences sectors powered by AvantAI® and our high-density compute capabilities,” said Tim Lantz, CEO of Avant Technologies. “At the same time, this exciting combination significantly strengthens our financial profile, offers massive commercial growth opportunities in one of Avant’s largest target markets, and bolsters our internal customer support and R&D capabilities.”
The goal of this deal is to bring together Avant Technologies and Wired-4-Health to improve how healthcare data is shared and used. By joining forces, they can use advanced AI and powerful computing to help healthcare and life sciences organizations deal with data and system challenges more easily and effectively.
This partnership improves the way transactions are processed, analyzes health outcomes, and ensures compliance, leading to better performance, more reliable data, and a more affordable, scalable system for customers.
“In the near term, if the healthcare industry expects to succeed in lowering costs while improving quality, the deployment of advanced AI, combined with more powerful, cost- effective compute capabilities will be critical to that success,” said Angela Harris, Avant’s Chief Operating Officer. “The addition of Wired-4-Health will position Avant as a key contributor in helping healthcare organizations solve complex problems at the intersection of cost, quality, compliance and technology.”
Tech giant Microsoft Corporation (NASDAQ:MSFT) (NEO:MSFT) has also been aiding the healthcare sector, most notably with its Azure AI Health Bot, which helps create copilot experiences with healthcare safeguards. Microsoft is enhancing its Azure AI Health Bot services by adding new healthcare-specific safeguards and features, including integration with Microsoft Copilot Studio.
These upgrades allow healthcare organizations to create their own copilot experiences, with pre-built capabilities, templates, and connectors tailored to healthcare needs, supporting protocol-based workflows alongside AI-based answers, and ensuring compliance with industry standards and guidelines. Now the platform is already being put into use by big players, including by German pharma giant Roche.
“By leveraging Azure AI Health Bot to build copilot experiences for doctors, we are developing an intuitive, conversational interface that lets clinicians access and explore Roche’s clinical documentations in a more natural way and to cope with the complexity and flood of information,” said Dr. Georg Isbary of Roche Pharma Germany. “The pilot for this new user experience, powered by generative AI features and compliant with the necessary security standards, has been integrated into our systems and will be further tailored to regional market needs.”
Long-time developer in the AI and machine learning (ML) space for healthcare, Health Catalyst, Inc. (NASDAQ:HCAT) signed a multi-year partnership with SacValley MedShare, one of California’s largest and most established qualified health information organization, earlier this year. As per the deal, Health Catalyst will support SacValley’s important mission through a broad set of technology solutions, including KPI Ninja by Health Catalyst, Healthcare.AI – a Health Catalyst Data Operating System (DOSTM) Platform module, and several other application solutions and Professional Services.
“We are honored to partner with SacValley MedShare on their continued journey to advance healthcare and are confident our technology, combined with our dedicated, skilled team members, will deliver the improved efficiency and support SacValley MedShare needs to achieve its healthcare transformation goals,” said Dan Burton, CEO of Health Catalyst.
By choosing Health Catalyst’s advanced data and analytics services, SacValley will enhance its ability to share and use information. This will lead to better service for those paying for healthcare, by making it easier to share important health details. This helps in delivering top-notch reports and care for patients.
“Transforming data from movable to usable is the alchemy of insights, turning raw potential into the gold of informed decision-making, ultimately forging a path towards health equity and improved outcomes,” said John Helvey, Executive Director of SacValley MedShare. “This is the primary reason SVMS chose Health Catalyst as a transforming partner.”
Another AI player is Ginkgo Bioworks Holdings, Inc. (NYSE:DNA), which is making it easier and cheaper for other biopharma companies to produce important biological materials and organisms by using artificial intelligence (AI). Back in February 2024, Ginkgo announced the acquisition of key assets of Reverie Labs, which has built and used AI/ML tools to accelerate drug discovery. The acquisition of Reverie’s infrastructure and software serves to help train large-scale AI foundation models, while four of Reverie’s key AI team members will also be joining Ginkgo.
Gingko followed this up through a collaboration with UK-based biotech company Prozomix, to build out the production of next generation enzyme plates for active pharmaceutical ingredient (API) manufacturing. The agreement aims to leverage Gingko’s Enzyme Services and industry-leading AI/ML models along with Prozomix’s existing enzyme libraries and deep experience manufacturing enzyme plates.
“API manufacturing is poised to greatly benefit from the latest in enzyme engineering and AI/ML enzyme models,” said Cindy Chang, Senior Director, Business Development at Ginkgo Bioworks. “We are so excited to partner with Prozomix to get enzymes into as many API routes as possible and help partners meet both their COGs savings and sustainability goals.”
Another developer helping to lead the way in AI-powered healthcare is Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX), which uses AI to pick out which treatments should be tested in clinical trials, while also letting biopharma companies to use their AI tools to do so also.
Last year, Recursion lined up a $50-million collaboration with AI chipmaking giant Nvidia for AI drug discovery. Then at the beginning of 2024, Recursion presented a demonstration of LOWE (Large Language Model-Orchestrated Workflow Engine), a new software designed to perform complex drug discovery tasks using a natural language interface. The platform is powered by Recursion’s proprietary biological and chemical data, and can orchestrate experiments using Recursion’s automated wet laboratories, unleashing the power of the Recursion Operating System in an easy-to-use tool.
“For the first time, we’ve taught Large Language Models to use many of Recursion’s tools and data in the same way an expert scientist would, but much more simply and in a more scalable way,” said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. “LOWE provides an exciting glimpse into what we believe the future of drug discovery will look like – a first step towards the development of autonomous ‘AI scientists’ for therapeutic discovery.”
Source: https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
CONTACT:USA News [email protected]
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Artificial Intelligence
Oncolytics Biotech® Announces Upcoming Presentations at the American Society of Clinical Oncology Annual Meeting
SAN DIEGO and CALGARY, AB, April 25, 2024 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the acceptance of two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place from May 31 – June 4, 2024, in Chicago, Illinois. Details on the abstracts and poster presentation are shown below.
Title: Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma.
Presentation Type: PosterAbstract Number: TPS4203Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and HepatobiliarySession Date and Time: June 1, 2024, 1:30 – 4:30 p.m. CTTitle: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer.Presentation Type: Online abstractAbstract Number: e14625
Abstracts will be published on the ASCO Annual Meeting website at 5:00 p.m. ET on May 23, 2024.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
[email protected]
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
[email protected]
View original content:https://www.prnewswire.co.uk/news-releases/oncolytics-biotech-announces-upcoming-presentations-at-the-american-society-of-clinical-oncology-annual-meeting-302127245.html
Artificial Intelligence
Internet of Things (IoT) Market to Expand at a Stellar 19.4% CAGR through 2031 | SkyQuest Technology
WESTFORD, Mass., April 25, 2024 /PRNewswire/ — SkyQuest projects that the Internet of Things (IoT) Market will attain a value of USD 1572.37 billion by 2031, with a CAGR of 19.4% over the forecast period (2024-2031). Internet of Things (IoT) refers to the network of connected devices over the internet that are embedded with sensors and software. Growing adoption of automation around the world and advancements in connected device technologies are forecasted to be key factors driving the Internet of Things (IoT) market growth in the future.
Download a detailed overview:
https://www.skyquestt.com/report/internet-of-things-market
Browse in-depth TOC on “Internet of Things (IoT) Market”
Pages – 197Tables – 69Figures – 75Internet of Things (IoT) Market Overview:
Report Coverage
Details
Market Revenue in 2023
$ 380.6 billion
Estimated Value by 2031
$1572.37 billion
Growth Rate
Poised to grow at a CAGR of 19.4%
Forecast Period
2024–2031
Forecast Units
Value (USD Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
Component Type, Application, and Region
Geographies Covered
North America, Europe, Asia Pacific, and the Rest of the world
Report Highlights
Updated financial information / product portfolio of players
Key Market Opportunities
Rising demand for connected healthcare and growing use of industrial automation solutions
Key Market Drivers
Advancements in connectivity and connected device technologies
Hardware is Estimated to Dominate the Global Market Share Owing to High Use of Hardware Components in IoT
Hardware components such as sensors and actuators are highly vital to the proper functioning of any kind of Internet of Things (IoT) device. Growing adoption of IoT devices in different industry verticals for various applications is promoting market growth via this segment. The development of new hardware solutions also helps this segment maintain its dominance.
Smart Agriculture is the Fastest-growing Segment Owing to Rising Adoption of Precision Agriculture Practice
Rising emphasis on improving agricultural yield and sustainability has resulted in the growing adoption of smart agriculture and precision agriculture practices. IoT devices play a crucial role in monitoring and controlling different elements of a smart agriculture setup that is mostly automated using different smart devices thereby contributing to the IoT market growth as well.
Growing Adoption of 5G Technology Allowing North America to Dominate the Global Internet of Things (IoT) Market
Rapid adoption of 5G technology and high use of cloud-based platforms are key factors allowing North America to lead the demand for Internet of Things (IoT) around the world. Surging investments in the research and development of advanced technologies and the presence of key tech giants such as Amazon, Google, IBM, and Microsoft also helps the dominance of this region. Canada and the United States remain the most lucrative markets for Internet of Things (IoT) companies in North America through 2031.
Request Free Customization of this report:
https://www.skyquestt.com/speak-with-analyst/internet-of-things-market
Internet of Things (IoT) Market Insights:
Drivers
Advancements in connectivity and connected device technologies.Growing demand for Industrial IoT (IIoT) solutions.Increasing number of smart cities and development of smart infrastructure.Restraints
Lack of standardization of IoT devices and technologies.Privacy and data security issues.Interoperability challenges and complex integration scenarios.Prominent Players in Internet of Things (IoT) Market
MicrosoftCisco SystemsIntelSiemens (Germany)AWS (US)Oracle (US)Qualcomm (UK)SAP (Germany)IBM (US)Google (US)View report summary and Table of Contents (TOC):
https://www.skyquestt.com/report/internet-of-things-market
Key Questions Answered in Internet of Things (IoT) Market Report
What are the top drivers for Internet of Things (IoT) market going forward?Who are the leading Internet of Things (IoT) market players?Where will demand for Internet of Things (IoT) be high?Which component accounts for a dominant revenue share of the global Internet of Things (IoT) market?This report provides the following insights:
Analysis of key drivers (advancements in connectivity and connected device technologies, growing demand for industrial IoT (IIoT), development of smart infrastructure for smart cities, growing use of smart devices ), restraints (lack of standardization, complexities in integration, concerns regarding security and privacy of data), and opportunities (rising popularity of connected healthcare, increasing adoption of Industry 4.0, rising use of industrial automation), influencing the growth of Internet of Things (IoT) market.Market Penetration: All-inclusive analysis of product portfolio of different market players and status of new product launches.Product Development/Innovation: Elaborate assessment of R&D activities, new product development, and upcoming trends of the Internet of Things (IoT) market.Market Development: Detailed analysis of potential regions where the market has potential to grow.Market Diversification: Comprehensive assessment of new product launches, recent developments, and emerging regional markets.Competitive Landscape: Detailed analysis of growth strategies, revenue analysis, and product innovation by new and established market players.Related Reports:
Global Internet of Things in Retail Market
Global Internet of Things (IoT) in Agriculture Market
Global Internet of Things (IoT) Microcontroller Market
Global IOT In Healthcare Market
Global IOT in Manufacturing Market
About Us:
SkyQuest is an IP focused Research and Investment Bank and Accelerator of Technology and assets. We provide access to technologies, markets and finance across sectors viz. Life Sciences, CleanTech, AgriTech, NanoTech and Information & Communication Technology.
We work closely with innovators, inventors, innovation seekers, entrepreneurs, companies and investors alike in leveraging external sources of R&D. Moreover, we help them in optimizing the economic potential of their intellectual assets. Our experiences with innovation management and commercialization has expanded our reach across North America, Europe, ASEAN and Asia Pacific.
Contact:
Mr. Jagraj Singh Skyquest Technology1 Apache Way,Westford,Massachusetts 01886USA (+1) 351-333-4748Email: [email protected] Our Website: https://www.skyquestt.com/
View original content:https://www.prnewswire.co.uk/news-releases/internet-of-things-iot-market-to-expand-at-a-stellar-19-4-cagr-through-2031–skyquest-technology-302127239.html
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